Intranasal Dexmedetomidine Versus Intranasal Midazolam as a Premedication in Pediatrics Undergoing Upper GI Endoscopy
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 70
- 主要终点
- Sedation status at separation from the parent
研究概览
简要总结
compare the effectiveness of intranasal dexmedetomidine and midazolam as a premedication in sedation of preschool children in GI endoscopy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children of preschool age (2-6 years old).
- •American scocity of anaesthesiology (ASA) I - II children.
- •Expected duration of the procedure is less than 50 minutes.
排除标准
- •Cardiac arrhythmia, congenital heart disease, or hemodynamic or respiratory instability; children at risk for airway obstruction.
- •Behavioral, mental or developmental abnormality (example: mental retardation, Attention Deficit Hyperactivity Disorder "ADHD", Autism, Down syndrome).
- •Regular intake of either brain stimulant or depressive drugs (example: Methylphenidate, amphetamine-dextroamphetamine and diazepam respectively).
- •Parent's refusal.
- •Emergency case.
- •Allergy to any of the used drugs
研究组 & 干预措施
dexmedetomidine group
patients will receive intranasal dexmedetomidine (1 microgram/kg) -Intranasal dexmedetomidine will be prepared from the 100 mcg/ml parenteral preparation in a 1-ml syringe, and 0.9% saline will be added to make a final volume of 1 ml- (0.5 ml will be administrated in each nostril) before starting the anesthesia with monitoring of sedation level and oxygen saturation.
干预措施: Dexmedetomidine (Drug)
midazolam group
patients will receive intranasal midazolam (0.2 mg/kg) up to 5 mg - Intranasal midazolam will be prepared from a 5 mg/ml parenteral preparation, and 0.9% saline will be added to make a final volume of one ml in a 1-ml syringe- (0.5 ml will be administrated in each nostril) before starting the anesthesia with monitoring of sedation level and oxygen saturation.
干预措施: Midazolam (Drug)
结局指标
主要结局
Sedation status at separation from the parent
时间窗: within 30 minutes after drugs administration
Parental separation anxiety scale (PSAS) ,A score of 1-2 was considered "satisfactory separation" and a score of 3-4 was considered "unsatisfactory separation."
次要结局
- Onset of sedation(within 30 minutes after drugs administration)
- awakening time(within 15 minutes after end of anaesthesia)
- post-operative emergence delirium and agitation.(within 30 minutes from recovery)
研究者
Marwa Mostafa Hasan Salem
Principal Investigator
Ain Shams University